BEUDAMED
    FDA Adverse Event Other Summary report: N

    6875 HANA OPERATING ROOM TABLE

    MDR report key: 2680314 · Received June 1, 2012

    Report

    Report Number
    2921578-2012-00011
    Event Type
    Other
    Date Received
    June 1, 2012
    Date of Event
    April 20, 2012
    Report Date
    May 31, 2012
    Manufacturer
    MIZUHO OSI
    Product Code
    JEA
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    UNKNOWN

    Narratives

    Additional Manufacturer Narrative · 1

    THE DEVICE IS SCHEDULED FOR EVAL. THE LOCKING MECHANISM ON THE CASTERS IS DESIGNED AND LABELED FOR LOCKING AND UNLOCKING WITH YOUR FOOT. THE HEALTHCARE WORKERS WERE USING THEIR HANDS. (B)(4).

    Description of Event or Problem · 1

    WHILE USING THE HANA OPERATING ROOM TABLE, THE STAFF EXPERIENCED INJURIES WHILE UNLOCKING THE CASTERS WITH THEIR HANDS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 6875 HANA OPERATING ROOM TABLE ORTHOPEDIC OPERATING ROOM TABLE JEA MIZUHO OSI 6875

    Patients

    Seq Age Sex Outcome Treatment
    1 Other